II 

115TH CONGRESS 

1ST SESSION S. 1528 

To amend the market name of genetically altered salmon in the United 

States, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 11, 2017 

Ms. MURKOWSKI (for herself, Mr. SULLIVAN, Ms. CANTWELL, and Mr. 

MERKLEY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the market name of genetically altered salmon 

in the United States, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Genetically Engineered 

5 Salmon Labeling Act’’. 

6 SEC. 2. PURPOSES. 

7 It is the purpose of this Act to— 

8 (1) ensure that consumers in the United States 

9 can make informed decisions when purchasing salm10 on; and 


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1 (2) authorize an independent scientific and 

2 technical advisory organization to conduct a review 

3 of— 

4 (A) the possible effects of genetically engi5 neered salmon on wild salmon stocks; and 

6 (B) the Food and Drug Administration’s 

7 approval of genetically engineered salmon for 

8 human consumption. 

9 SEC. 3. MARKET NAME FOR GENETICALLY ENGINEERED 

10 SALMON. 

11 (a) IN GENERAL.—Notwithstanding any other provi12 sion of law, for purposes of applying the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the ac14 ceptable market name of any salmon that is genetically 

15 engineered shall include the words ‘‘Genetically Engi16 neered’’ or ‘‘GE’’ prior to the existing acceptable market 

17 name. 

18 (b) DEFINITION.—For purposes of this section, salm19 on is genetically engineered if it has been modified by re20 combinant DNA (rDNA) techniques, including the entire 

21 lineage of salmon that contain the rDNA modification. 

22 SEC. 4. THIRD-PARTY REVIEW OF CERTAIN SALMON AP23 PROVAL. 

24 (a) INDEPENDENT SCIENTIFIC ORGANIZATION RE25 VIEW AND REPORT.—The Secretary of Health and 


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1 Human Services (referred to in this section as the ‘‘Sec2 retary’’) shall ensure that the National Academy of 

3 Sciences, or a similar independent scientific and technical 

4 advisory organization, conducts a review of, and submits 

5 to the Secretary a report on— 

6 (1) the environmental assessment carried out by 

7 the Food and Drug Administration and released on 

8 November 12, 2015, in support of approval of the 

9 new animal drug application under section 512 of 

10 the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 360b) with respect to AquAdvantage Salmon, 

12 taking into account the impact of AquAdvantage 

13 Salmon on wild stocks of salmon and related wild 

14 ecosystems; and 

15 (2) each environmental assessment carried out 

16 by the Food and Drug Administration in support of 

17 an approval of a new animal drug application under 

18 section 512 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 360b) related to a genetically 

20 engineered finfish intended for human consumption. 

21 (b) SECOND FDA ENVIRONMENTAL ASSESSMENT.— 

22 After receipt of a report under paragraph (1) or (2) of 

23 subsection (a), the Secretary shall conduct a second envi24 ronmental assessment with respect to approval of the apVerDate Sep 11 2014 03:04 Jul 15, 2017 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1528.IS S1528

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1 plication described in such paragraph (1) or (2), taking 

2 into account the findings in such report. 

3 (c) EFFECTIVE DATE OF APPROVAL.—Notwith4 standing any other provision of law, the approval of a new 

5 animal drug application with respect to which review of 

6 an environmental assessment is required under subsection 

7 (a) shall not take effect until the Secretary completes a 

8 second environmental assessment under subsection (b). 

Æ 


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